Browse Device Recalls

1,490 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,490 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,490 FDA device recalls.

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DateProductReasonClassFirm
Feb 10, 2020 Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
Feb 10, 2020 Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
Feb 10, 2020 Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expirat... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
Jan 21, 2020 Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 e... The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... Class II Medline Industries Inc
Jan 21, 2020 Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTI... The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... Class II Medline Industries Inc
Jan 7, 2020 Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malays... There is potential for the sterile wrap to become loose while in transit and compromise the steri... Class II Medline Industries Inc
Oct 30, 2019 Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end... Class II Medline Industries Inc
Sep 18, 2019 EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil p... Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. Class II Medline Industries Inc
Sep 6, 2019 MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: ... The recall is being conducted due to a potential defective component on the circuit board causing... Class II Medline Industries Inc
Aug 9, 2019 Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigati... Samples in the identified lot were found to have incomplete or open packaging seals. Class II Medline Industries Inc
May 30, 2019 Anti-fog solution packaged in a Tyvek peel pouch and it is placed into variou... The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties. Class II Medline Industries, Inc.
May 28, 2019 SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage... Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class II Medline Industries Inc
May 28, 2019 SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usag... Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class II Medline Industries Inc
May 28, 2019 SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage:... Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class II Medline Industries Inc
May 10, 2019 Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code ... This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to... Class I Medline Industries Inc
May 3, 2019 Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warm... The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum leve... Class I Medline Industries Inc
Apr 25, 2019 Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: T... Potential risk of brush detachment during cleaning. If brush detachment is not identified, there... Class II Medline Industries Inc
Jan 31, 2019 Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR... Potential for the Semi-Rigid canister lid to fragment during use. Class II Medline Industries Inc
Aug 30, 2018 Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers... Firm received sporadic reports of discoloration on certain lots of the product, which has been id... Class II MEDLINE INDUSTRIES INC
Jun 15, 2018 Endoscopic Cleaning Brush, single use, sold in kits and labeled as the follow... There is potential risk of brush detachment during cleaning. If brush detachment is not identifi... Class II Medline Industries Inc
Apr 24, 2018 MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: ... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / ... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet /... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Apr 24, 2018 MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC... The product packaging seal has the potential to experience seal creep. This may result in gaps to... Class II Medline Industries Inc
Feb 1, 2018 Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR ... Packaged with an incorrect overwrap. Class II Medline Industries Inc
Jan 12, 2018 BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile... One of the cases of product might not have been sterilized. Class II Medline Industries, Inc.
Oct 23, 2017 Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pou... Possible open seal on top portion of the package. Could cause breach of sterility. Class II Medline Industries Inc
Oct 18, 2017 Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (... Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled... Class II Bioseal Corporation
Oct 16, 2017 DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep ... Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled ... Class II DeRoyal Industries Inc
Oct 10, 2017 MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8 Products labeled as sterile were distributed prior to sterilization Class II Medline Industries Inc
Oct 10, 2017 MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHE... Products labeled as sterile were distributed prior to sterilization Class II Medline Industries Inc
Aug 10, 2017 Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic ba... The locking mechanism on the belt may fail to secure/hold the strap when in locked position poten... Class II Medline Industries Inc
Aug 10, 2017 Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic ba... The locking mechanism on the belt may fail to secure/hold the strap when in locked position poten... Class II Medline Industries Inc
Jul 18, 2017 Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek pla... Product did not undergo correct sterilization procedures and may potentially be non-sterile. Class II Medline Industries Inc
Apr 12, 2017 LASER CDS Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep"... Class II Medline Industries, Inc.
Apr 12, 2017 Laparoscopy CDS One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled st... Class II Medline Industries, Inc.
Apr 12, 2017 Cardiac Insulation Pad, OPEN HEART CDS Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation ... Class II Medline Industries, Inc.
Apr 12, 2017 PICC Tray, STERILE, 12 packs each per case. Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit com... Class II Medline Industries, Inc.
Apr 12, 2017 Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit com... Class II Medline Industries, Inc.
Dec 14, 2016 10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for:... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for:... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medl... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: ... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 14, 2016 14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medl... Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... Class II MEDLINE INDUSTRIES INC
Dec 12, 2016 Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL ... Product was not sterilized. Product was shipped to distribution centers instead of the sterilizat... Class II MEDLINE IND
Nov 23, 2016 Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in ... Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage... Class II Medline Industries Inc
Aug 29, 2016 Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier ... Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Aug 29, 2016 BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H... Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... Class II Angiodynamics Inc. (Navilyst Medical Inc.)

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.